Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Gel for up to a Year in Scalp Psoriasis

NCT00216879 | Completed Phase 3

• 1 other identifier: MBL 0407 INT
• Study Type: interventional
• Target: 800
• Locations: 5 countries
• Sites: 5

Brief Summary

The purpose of the trial is to study the safety and efficacy of long term use of once daily applications, as needed, of calcipotriol plus betamethasone dipropionate gel, as compared to calcipotriol alone in the same gel. The primary response criteria will be the incidence of adverse drug reactions of any type, and the incidence of adverse events of concern associated with long-term corticosteroid use on the scalp.

Conditions

Psoriasis of Scalp

Outcome Measures

Primary Outcomes (1)

• The proportions of patients who experience adverse drug reactions and the proportion of patients who experience adverse events of concern associated with long-term topical corticosteroid use on the scalp during the study

Secondary Outcomes (1)

• Percentage of post-baseline satisfactorily controlled assessments according to the Investigators' Global Assessment of disease severity during the study

Interventions

Calcipotriol plus betamethasone dipropionate gel (LEO 80185) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scalp psoriasis amenable to topical treatment with a maximum of 100 g of study medication per week
• Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs
• Extent of scalp psoriasis involving more than 10% of the total scalp area
• Disease severity on the scalp graded as Moderate, Severe or Very Severe according to the Investigator's Global Assessment of disease severity

You may not qualify if:

• PUVA or Grenz ray therapy anywhere on the patient within 28 days prior to randomisation
• UVB therapy anywhere on the patient within 14 days prior to randomisation
• Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on, scalp psoriasis (e.g., alefacept, efalizumab, etanercept, infliximab) within 6 months prior to randomisaiton
• Systemic treatments with a potential effect on scalp psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within 28 days prior to randomisation
• Any topical treatment for scalp psoriasis or any other skin disease on the scalp (excluding medicated shampoos, emollients and hair conditioners) within 14 days prior to randomisaiton
• Topical treatment for other skin disorders with very potent WHO group IV corticosteroids within 14 days prior to randomisation
• Planned initiation of, or changes in dose of concomitant medication that could affect scalp psoriasis (e.g., beta blockers, antimalarial drugs, lithium) during the study
• Current diagnosis of guttate, pustular, exfoliative or erythrodermic psoriasis
• Patients with any of the following conditions present on the scalp area: viral lesions, fungal and bacterial skin infections, parasitic infections and atrophic skin
• Known or suspected severe renal insufficiency or severe hepatic disorders
• Patiens with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia
• Trial subjects should be using an adequate method of contraception

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (5)

Clinique de Dermatologie

Moncton, E1C 8X3, Canada

Location

Hørsholm Hospital, Dermatological Department

Hørsholm, 2970, Denmark

Location

Hôpital Nord, Service de Dermatologie

Saint-Etienne, 42055, France

Location

Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten

Münster, 48179, Germany

Location

Monklands Hospital, Department of Dermatology

Airdrie, ML6 6JS, United Kingdom

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Interventions

calcipotriene

Study Officials

• T A Luger, Dr. med.

  Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: February 1, 2005
• Study Completion: July 1, 2006
• Last Updated: February 24, 2025

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); DE (1); FR (1); DK (1); GB (1)